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FDA Clears Quidel Rapid MDx Strep Test

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market Quidel's new Solana® Strep Complete Assay for the rapid and qualitative detection and differentiation of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) and Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus) nucleic acids isolated from throat swab specimens obtained from symptomatic patients. Specimens identified as negative by the Solana assay do not require additional testing by culture.

Group A Streptococcus are Gram-positive bacteria, primarily residing in the nose, throat and skin; they are responsible for several illnesses, ranging from strep throat or skin infections to severe illnesses (necrotizing fasciitis, or streptococcal toxic shock syndrome). (1) Strep throat, or streptococcal pharyngitis, is the most common illness from Group A Streptococcus infections. These bacteria are spread through contact with airborne droplets from an infected person's cough, sneeze or via contaminated items such as eating utensils. (2) Streptococcus dysgalactiae is a species of pyogenic beta-hemolytic Streptococcus C/G commonly isolated from humans. (3) Most infections are treated with penicillin or other beta-lactams.

The Solana Strep Complete Assay accurately differentiates pyogenic Group A from pyogenic Group C or G. Non-group A strains, especially Group C&G, are found in a significant number of Group A negative symptomatic patients (≥20%) and treatment appears to shorten the symptomatic period of the disease. (4)

The Solana Strep Complete Assay is an easy-to-use, rapid molecular diagnostic test that has superb clinical accuracy and does not require culture confirmation of negative results, an industry first for Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus). The assay requires no upfront extraction of DNA and generates an accurate result in approximately 25 minutes.

The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel's AmpliVue® molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each 25-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings.

"We are very pleased to receive FDA clearance for a definitive, comprehensive diagnostic for Streptococcal infections, and along with our recently-cleared Solana Influenza A+B Assay, comes just in time for the upcoming respiratory disease season," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "With the Solana system, we've given moderately complex labs what they want: a platform that provides definitive test results quickly, and in a scalable connected format with a low total cost of ownership. We believe that Solana's utility and value will continue to increase with the launch of each additional assay."

Solana® Strep Complete is Quidel's fourth molecular diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format. Solana® Influenza A+B received 510(k) clearance in September, Solana® Trichomonas assay received 510(k) clearance in August, and Solana® Group A Strep assay was cleared in June 2015.

With the Solana franchise, Quidel has grown its number of molecular platforms that are FDA cleared and available commercially: non-instrumented AmpliVue® for lower-volume moderately complex labs; and Lyra® reagents for higher throughput, highly complex laboratories with existing PCR infrastructure.

3. Vieira V, Teixeira L, Zahner V, et al. Genetic relationships among the different phenotypes of Streptococcus dysgalactiae strains. Int J Syst Bacteriol 1998; 48:1231-43.
4. Zwart, S. et al BMJ 2000;320:150-4

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